Medical Device Package Integrity Testing

Pacific BioLabs performs the dye penetration and the microbial challenge package integrity tests. Package integrity tests are used to detect packaging problems that could adversely affect the sterility of a medical device. Sterile products are subjected to an environmental stress intended to simulate extreme conditions that a product might encounter in shipping or storage. The product packaging is then subjected to microbial challenge or dye penetration testing to determine if it has retained its properties as a microbial barrier.

Package Integrity Tests

  • Package Integrity by Microbial Challenge (26 samples recommended)
  • Package Integrity by Dye Penetration (13 samples recommended)
  • Burst Strength Test *
  • Seal Peel *

* denotes a subcontracted test

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